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临床试验/NCT03440294
NCT03440294已完成不适用

Étude de l'Effet de la Combinaison néoprène et de l'équipement Individuel de Flottaison Sur la Fonction Respiratoire de Repos et Les capacités à l'Effort Chez Les véliplanchistes : étude WINDSURF

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Forced Vital Capacity (FVC in L) at rest.

研究概览

简要总结

The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.

详细描述

Windsurfers will perform resting spirometry and exercise test on cycle ergometer until exhaustion in two conditions: with or without equipment. The investigators will measure Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption, ventilation at each step of the incremental exercise and at exhaustion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Male or female aged 18 to 35
  • •Do not contraindicate any of the investigations in the study
  • •Being affiliated to a social security system
  • •free, informed and written consent
  • •Have already performed a cardiopulmonary exercise test without any electrocardiographic abnormality
  • •Subject practicing windsurfing (whatever the level of practice (leisure or competition))

排除标准

  • •Subjects < 18 years old
  • •Pregnant woman
  • •Inability to consent
  • •Taking any of the following: oral or inhaled Beta 2 short-acting or long-acting mimetics, oral or inhaled corticosteroids, oral anti-leukotrienes.
  • •Abnormalities in the resting ECG pattern

研究组 & 干预措施

with neoprene suit and life jacket

Other

Realization of the following examinations WITH neoprene suit and life jacket :

  • resting standard spirometry
  • maximum exercise testing. No drug and no placebo will be used in this arm.

干预措施: resting standard spirometry (Diagnostic Test)

with neoprene suit and life jacket

Other

Realization of the following examinations WITH neoprene suit and life jacket :

  • resting standard spirometry
  • maximum exercise testing. No drug and no placebo will be used in this arm.

干预措施: maximum exercise testing (Diagnostic Test)

without neoprene suit and life jacket

Other

Realization of the following examinations WITHOUT neoprene suit and life jacket :

  • resting standard spirometry
  • maximum exercise testing. No drug and no placebo will be used in this arm.

干预措施: resting standard spirometry (Diagnostic Test)

without neoprene suit and life jacket

Other

Realization of the following examinations WITHOUT neoprene suit and life jacket :

  • resting standard spirometry
  • maximum exercise testing. No drug and no placebo will be used in this arm.

干预措施: maximum exercise testing (Diagnostic Test)

结局指标

主要结局

Forced Vital Capacity (FVC in L) at rest.

时间窗: 1 day

spirometry at rest

次要结局

  • Peak Flow(1 day)
  • Forced Expiratory Volume(1 day)
  • maximal ventilation(1 day)
  • oxygen consumption(1 day)
  • tidal volume(1 day)
  • carbon dioxide production(1 day)
  • breathing frequency(1 day)
  • mean flow rates(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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